Intellectual Property

Our intellectual property portfolio encompasses approximately 800 patents or patent applications across 69 patent families, which we believe provides substantial competitive advantages for the commercial development of our cell-based therapies in major markets including the United States, Europe, Japan and China.

We have a large patent portfolio of issued and pending claims covering compositions of matter and uses for our Mesenchymal Lineage Adult Stem Cell (MLC)-based technologies and other proprietary regenerative product candidates and technologies, as well as for elements of our manufacturing processes.

One of our major objectives is to continue to protect and expand our extensive estate of patent rights and trade secrets. We believe this enables us to deliver commercial advantages and long-term protection for our product candidates based on our proprietary technologies. Additionally this supports our corporate strategy to target large, mature and emerging healthcare markets for our exploratory therapeutic product candidates.

More specifically, our patent estate includes issued patent and patent applications in major markets, including the United States, Europe and Japan.

Cell-based technology and product candidates

The patents that we have obtained, and continue to apply for, cover MLC technologies and product candidates derived from these technologies, irrespective of the tissue source, including bone marrow, adipose, placenta, umbilical cord and dental pulp.

These patents cover, among other technology areas, a variety of MLCs, including Mesenchymal Precursor Cells (MPCs) and Mesenchymal Stem Cells (MSCs), and the use of MLCs for expansion of hematopoietic stem cells (HSCs). Among the indication-specific issued or pending patents covering product candidates derived from our MLCs are those which provide commercial support for our Tier 1 product candidates - chronic heart failure, chronic low back pain due to disc degeneration, acute graft versus host disease, and chronic inflammation conditions including biologic refractory rheumatoid arthritis, and diabetic nephropathy .

We also have issued and pending patents covering all of our Tier 2 and pipeline indications, including rheumatoid arthritis, type 2 diabetes and its complications, inflammatory bowel disease (e.g. Crohn’s disease), neurologic diseases, and orthopedic disorders.

In addition, in many major jurisdictions we may be able to extend commercial exclusivity period for our product candidates, which include, but are not limited to the exclusive right to reference our data, orphan drug exclusivity and patent term extensions.

Manufacturing

Our patent portfolio also includes issued and pending coverage of proprietary manufacturing processes that are being used with our current two-dimensional (2D) manufacturing platform as well as the three-dimensional (3D) bioreactor manufacturing processes currently under development. These cell manufacturing patents cover isolation, expansion, purification, scale up, culture conditions, aggregates minimization, cryopreservation, release testing and potency assays.